Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397)
Description
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System by Philips Medical Systems Nederland B.V., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251397
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR ... | Philips Medical Systems Nederland B.V. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition ... | Philips Medical Systems Nederland B.V. | 2026 |
Trace the full predicate network for K251397
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.